Pilot Study of Alternative Treatments of Unexplained Chronic Fatigue

NCT00983502 | Terminated

• 2 other identifiers: 25988R21AT004537-02
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators' long-term goal is to identify, and then provide general practitioners with evidence-based recommendations for therapeutic interventions for unexplained chronic fatigue (UCF). The investigators' central hypothesis guiding this application is that some complimentary and alternative medicine (CAM) practitioners have developed management approaches that are more helpful to patients with UCF than usual care.

Conditions

Idiopathic Chronic Fatigue; Chronic Fatigue Syndrome; Myalgic Encephalomyelitis

Keywords

Idiopathic Chronic Fatigue; Chronic Fatigue Syndrome; Myalgic encephalomyelitis

Outcome Measures

Primary Outcomes (1)

• Differences among four groups of clinicians with respect to patient treatment outcome

  Six months

Study Arms (4)

Integrative Medicine

Patients of MD practitioners trained in Complementary and Alternative Medicine

Naturopath Doctors

Patients of practitioners who are not MD's and are trained in Naturopathic Medicine

Chronic Fatigue Specialists

Patients of MD's who specialize in treating Chronic Fatigue and related conditions

Control Group

Patients treated by primary care MDs in practice-based research networks

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The primary analyses will compare outcomes for 240 patients in four main groups (60 in each group) defined by the background of the treating clinicians. Study subjects will be UCF patients new to the practice of one of four groups of participating clinicians.

You may qualify if:

• Age 21 through 65.
• Has severe debilitating fatigue that substantially reduces the quality of life.
• The severe, unexplained fatigue has persisted for at least six months.
• Has not been previously treated by current physician for chronic fatigue.
• Can speak and read English.
• Is not pregnant or planning to become pregnant within six months.
• Has a telephone.

You may not qualify if:

• No known history of:
• Bipolar disorder
• Psychosis
• Major Depressive Disorder
• Sleep disorder
• Anemia
• Thyroid disease
• Rheumatoid Arthritis
• Systemic Lupus
• Cancer
• Heart disease
• Liver disease

Sponsors & Collaborators

• University of Utah: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arthur J Hartz, MD, PhD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 15, 2011

Record last verified: 2011-12

Locations

US (1)